TOKYO-Neoadjuvant therapy with the taxane docetaxel (Taxotere) is well tolerated and boosts survival over local treatment alone in patients with radically treatable, locally advanced non-small-cell lung cancer (NSCLC), investigators reported at the Ninth World Conference on Lung Cancer.
TOKYONeoadjuvant therapy with the taxane docetaxel (Taxotere) is well tolerated and boosts survival over local treatment alone in patients with radically treatable, locally advanced non-small-cell lung cancer (NSCLC), investigators reported at the Ninth World Conference on Lung Cancer.
The results are from a multicenter phase III trial that enrolled 274 men and women with histologically and cytologically confirmed, previously untreated stage III NSCLC.
One group received docetaxel 100 mg/m² administered intravenously once every 3 weeks for three consecutive cycles, followed by local treatment involving radical surgery or radiotherapy. The other group underwent immediate radical local treatment.
Patients were stratified by disease stage and treatment center. The choice of radical local treatment was made at the discretion of the treating physician.
The two treatment arms were similar with respect to the ratio of men to women, median age, World Health Organization (WHO) performance status, tumor histology, and disease stage.
The median survival was 15 months in patients who received neoadjuvant docetaxel prior to local treatment and 13 months in patients receiving only local treatment, reported Karin V. Mattson, MD, professor of medicine, University of Helsinki, Finland. The difference between the two groups was statistically significant.
The median survival in stage IIIA T3 patients who received neoadjuvant docetaxel was also significantly longer than the median survival in the control group (19 months vs 13 months, respectively).
Febrile neutropenia was uncommon. The use of docetaxel did not have a deleterious effect on the ability of patients to receive definitive local therapy. In addition, the treatment groups were similar in the frequency of pneumonitis and esophagitis secondary to radiotherapy.
This study, which is the largest randomized investigation thus far of the role of neoadjuvant therapy in stage III lung cancer, strengthens the findings of two smaller trials that have reported a survival advantage associated with neoadjuvant chemotherapy in patients with operable stage IIIA non-small-cell lung cancer, Dr. Mattson said.
She noted that all three studies underscore the benefit of combined modality treatment in the management of stage III disease, compared with conventional local treatment alone.
The results also show that single-agent docetaxel is a useful nonplatinum alternative for neoadjuvant chemotherapy in stage III NSCLC, she said. Prior research had shown a small survival advantage for patients given cisplatin-based neoadju-vant therapy prior to definitive local therapy; however, the approach was limited by significant cisplatin-based toxicity.
Finally, Dr. Mattson emphasized that because of the heterogeneity of stage III disease and the variability in prognostic factors in individual patients, more studies are needed to determine which patients with stage III disease are the best candidates for combined modality treatment.